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CompletedNCT03433456HABITSUpdated Oct 29, 2024Results posted

Healthy Homes, Healthy Habits

An interventional study of Home visitation + HABITS program and Standard home visitation program in Obesity, Obesity, Childhood and Obesity; Familial, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 0 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.

Primary conditionPediatric ObesityRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pediatric Obesity
Why
  1. The study's listed conditions name Pediatric Obesity, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
296
Allocation
Randomized
Ages
0 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.

Read the detailed description

Participants will be 140 mothers (>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive \~15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors.

Mothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.

02

Conditions studied

  • Obesity
  • Obesity, Childhood
  • Obesity; Familial

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Keywords

  • obesity
  • low-income
  • health disparities
  • home visitation
  • prevention
  • childhood obesity
  • habit
03

In context

Pediatric Obesity Reclassified

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 296 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Browse University of Alabama at Birmingham studies →

Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
0 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.

Mothers or Primary Caregivers:

  • Age 18-75 years of age
  • Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama.
  • Mother or primary caregiver of 0-4 year old child
  • Generally Healthy

Children:

  • 0-4 years of age at time of enrollment
  • Parent or primary caregiver enrolled in First Teacher

Exclusion criteria

Exclusion Criteria:

Mothers or primary caregivers:

  • Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.

Children:

  • Child has a history of a feeding or eating disorder
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
296 participants (actual)

Study arms

  • Experimental
    Home visitation + HABITS Program

    The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.

    Behavioral: Home visitation + HABITS program · Behavioral: Standard home visitation program

  • Active comparator
    Standard home visitation program

    Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.

    Behavioral: Standard home visitation program

Interventions

  • BehavioralHome visitation + HABITS program

    The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.

  • BehavioralStandard home visitation program

    Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.

06

What researchers measure

Primary outcomes

  1. Weight of Mothers

    Body weight (kg) at baseline and follow-up assessments.

    Time frame: Baseline, 6 months, 12 months

  2. Weight of Children

    Body weight (kg) at baseline and follow-up assessments..

    Time frame: Baseline, 6 months, 12 months

Secondary outcomes

  1. Habit Strength of Targeted Behaviors

    Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.

    Time frame: Baseline, 6 months, 12 months

  2. Household Environment Assessing the Number of Different Food Items Available

    Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.

    Time frame: Baseline, 6 months, 12 months

  3. Household Environment Assessing the Number of Different Activity-promoting Items Available

    Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.

    Time frame: Baseline, 6 months, 12 months

Other outcomes

  1. Maternal Eating Practices

    Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.

    Time frame: Baseline, 6 months, 12 months

  2. Maternal Feeding Practices

    Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.

    Time frame: Baseline, 6 months, 12 months

  3. Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)

    The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.

    Time frame: Baseline, 6 months, 12 months

  4. Number of Caregivers With Changes to Their Medical History

    Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.

    Time frame: 6 months, 12 months

07

Results

Posted Apr 24, 2024
Limitations and caveats
Due to COVID-19, there were protocol changes to the study and no data available for some of the 6-month study visits.

Participant flow

Participant flow — Overall Study
MilestoneHome Visitation + HABITS ProgramStandard Home Visitation Program
Started158138
Caregivers started7969
Children started7969
Caregivers completed7163
Children completed7163
Completed142126
Not completed1612
Withdrew: Death11
Withdrew: Lost to follow-up1411
Withdrew: Pt in icu and unable to complete follow-up visit10

Outcome measures

PrimaryWeight of Mothers

Body weight (kg) at baseline and follow-up assessments.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Kilograms
Weight of Mothers
KilogramsHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline88.65 ± 26.0497.43 ± 31.29
6-months85.96 ± 27.0196.52 ± 28.97
12-months85.94 ± 23.7898.75 ± 30.77
PrimaryWeight of Children

Body weight (kg) at baseline and follow-up assessments..

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Kilograms
Weight of Children
KilogramsHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline13.88 ± 3.8014.23 ± 5.10
6-months15.40 ± 3.7615.94 ± 5.21
12-months16.83 ± 3.9517.58 ± 5.80
SecondaryHabit Strength of Targeted Behaviors

Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Score on a scale
Habit Strength of Targeted Behaviors
Score on a scaleHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline- Fruit3.58 ± 0.963.67 ± 0.91
6-month- Fruit3.86 ± 0.813.95 ± 0.71
12-month- Fruit3.91 ± 0.964.26 ± 0.80
Baseline-Vegetables3.72 ± 1.003.79 ± 0.84
6-month-Vegetables3.91 ± 0.824.07 ± 0.73
12-month-Vegetables4.02 ± 1.014.18 ± 0.84
Baseline-Fried Food3.30 ± 1.092.99 ± 1.01
6-month-Fried Food2.95 ± 1.092.89 ± 1.10
12-month-Fried Food2.96 ± 1.073.13 ± 1.09
Baseline-SSB3.41 ± 1.143.13 ± 1.18
6-month-SSB2.80 ± 1.132.98 ± 1.13
12-month-SSB3.19 ± 1.223.27 ± 1.20
Baseline-Activity4.09 ± 0.833.99 ± 0.78
6-month-Activity4.12 ± 0.734.08 ± 0.61
12-month-Activity4.13 ± 0.784.29 ± 0.56
SecondaryHousehold Environment Assessing the Number of Different Food Items Available

Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Available food items
Household Environment Assessing the Number of Different Food Items Available
Available food itemsHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline-Fruit Availability5.01 ± 3.145.64 ± 3.75
6-month-Fruit Availability6.00 ± 3.895.58 ± 3.40
12-month-Fruit Availability5.28 ± 3.115.66 ± 2.72
Baseline-Vegetable Availability7.46 ± 3.667.29 ± 3.65
6-month-Vegetable Availability6.69 ± 4.017.89 ± 4.56
12-month-Vegetable Availability7.14 ± 3.837.34 ± 3.37
Baseline-Fried Food3.61 ± 3.053.30 ± 2.41
6-month-Fried Food3.72 ± 2.653.71 ± 2.15
12-month-Fried Food4.08 ± 2.683.71 ± 2.36
Baseline-SSB4.44 ± 2.893.84 ± 2.27
6-month-SSB4.26 ± 2.664.09 ± 2.37
12-month-SSB3.96 ± 2.433.68 ± 2.45
SecondaryHousehold Environment Assessing the Number of Different Activity-promoting Items Available

Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Available activity items
Household Environment Assessing the Number of Different Activity-promoting Items Available
Available activity itemsHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline3.96 ± 1.773.81 ± 1.58
6-month4.59 ± 2.114.40 ± 2.15
12-month4.30 ± 1.624.74 ± 2.17
Other pre-specifiedMaternal Eating Practices

Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Score on a scale
Maternal Eating Practices
Score on a scaleHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline-Fruit2.67 ± 1.732.33 ± 1.36
6-month-Fruit3.11 ± 1.682.57 ± 1.38
12-month-Fruit2.94 ± 1.762.94 ± 1.61
Baseline-Vegetable2.99 ± 1.422.49 ± 1.35
6-month-Vegetable2.61 ± 1.422.66 ± 1.25
12-month-Vegetable2.73 ± 1.492.84 ± 1.43
Baseline-Fried Food1.96 ± 1.461.23 ± 0.97
6-month-Fried Food1.65 ± 1.291.37 ± 1.14
12-month-Fried Food1.38 ± 1.091.35 ± 1.17
Baseline-Soda2.35 ± 2.041.72 ± 1.89
6-month-Soda1.52 ± 1.441.48 ± 1.57
12-month-Soda1.66 ± 1.711.77 ± 1.88
Baseline-Walk4.30 ± 1.844.16 ± 1.94
6-month-Walk5.25 ± 1.524.78 ± 1.75
12-month-Walk5.14 ± 1.534.95 ± 1.61
Other pre-specifiedMaternal Feeding Practices

Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Score on a scale
Maternal Feeding Practices
Score on a scaleHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline-Fruit4.19 ± 1.964.14 ± 1.88
6-month-Fruit4.46 ± 1.734.54 ± 1.45
12-month-Fruit4.27 ± 1.654.37 ± 1.54
Baseline-Vegetable4.03 ± 1.873.70 ± 1.74
6-month-Vegetable3.81 ± 1.694.02 ± 1.52
12-month-Vegetable3.86 ± 1.553.77 ± 1.62
Baseline-Fried Food2.63 ± 1.702.13 ± 1.37
6-month-Fried Food2.37 ± 1.142.29 ± 1.27
12-month-Fried Food2.28 ± 1.242.11 ± 0.70
Baseline- Soda1.73 ± 1.641.46 ± 1.28
6-month-Soda1.72 ± 1.351.68 ± 1.32
12-month-Soda1.72 ± 1.221.85 ± 1.34
Baseline-Activity5.43 ± 1.895.22 ± 2.15
6-month-Activity6.46 ± 1.186.09 ± 1.45
12-month-Activity6.04 ± 1.615.92 ± 1.85
Other pre-specifiedCaregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)

The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · Score on a scale
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
Score on a scaleHome Visitation + HABITS ProgramStandard Home Visitation Program
Baseline4.59 ± 4.194.42 ± 4.39
6-months3.48 ± 3.643.08 ± 3.56
12-months3.64 ± 3.563.03 ± 3.70
Other pre-specifiedNumber of Caregivers With Changes to Their Medical History

Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.

Time frame:
6 months, 12 months
Reported as:
Count of participants · Participants
Number of Caregivers With Changes to Their Medical History
ParticipantsHome Visitation + HABITS ProgramStandard Home Visitation Program
6-months — Had a change to medical history in last 6-months24
6-months — No change to medical history in last 6-months5161
12-months — Had a change to medical history in last 6-months32
12-months — No change to medical history in last 6-months6860

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Home Visitation + HABITS Program: Caregivers0/79 (0%)0/79 (0%)0/79 (0%)
Home Visitation + HABITS Program: Children1/79 (1.3%)1/79 (1.3%)0/79 (0%)
Standard Home Visitation Program: Caregivers1/69 (1.4%)1/69 (1.4%)0/69 (0%)
Standard Home Visitation Program: Children0/69 (0%)0/69 (0%)0/69 (0%)
Most frequent serious events
Most frequent serious events
EventHome Visitation + HABITS Program: CaregiversHome Visitation + HABITS Program: ChildrenStandard Home Visitation Program: CaregiversStandard Home Visitation Program: Children
HospitalizationInfections and infestations0/791/791/690/69

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Home Visitation + HABITS ProgramStandard Home Visitation ProgramTotal
Caregivers — <=18 years000
Caregivers — Between 18 and 65 years7968147
Caregivers — >=65 years011
Children — <=18 years7969148
Children — Between 18 and 65 years000
Children — >=65 years000
Age, Continuous
Age, Continuous(Years)Home Visitation + HABITS ProgramStandard Home Visitation ProgramTotal
Caregivers31.52 ± 6.8332.52 ± 9.6631.98 ± 8.26
Children2.71 ± 1.242.59 ± 1.222.66 ± 1.22
Sex: Female, Male
Sex: Female, Male(Participants)Home Visitation + HABITS ProgramStandard Home Visitation ProgramTotal
Caregivers — Female7869147
Caregivers — Male101
Children — Female403474
Children — Male393574
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Home Visitation + HABITS ProgramStandard Home Visitation ProgramTotal
Caregivers — Hispanic or Latino639
Caregivers — Not Hispanic or Latino7366139
Caregivers — Unknown or Not Reported000
Children — Hispanic or Latino628
Children — Not Hispanic or Latino7367140
Children — Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Home Visitation + HABITS ProgramStandard Home Visitation ProgramTotal
Caregivers — American Indian or Alaska Native000
Caregivers — Asian000
Caregivers — Native Hawaiian or Other Pacific Islander000
Caregivers — Black or African American6053113
Caregivers — White151126
Caregivers — More than one race145
Caregivers — Unknown or Not Reported314
Children — American Indian or Alaska Native000
Children — Asian000
Children — Native Hawaiian or Other Pacific Islander000
Children — Black or African American6155116
Children — White14822
Children — More than one race268
Children — Unknown or Not Reported202
08

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35205, United States
09

References and documents

Publications

  • Salvy SJ, Dutton GR, Borgatti A, Kim YI. Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol. Contemp Clin Trials. 2018 Jul;70:88-98. doi: 10.1016/j.cct.2018.05.015. Epub 2018 May 24. PubMed 29802965 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — With the documented permission of the IRB, the PI may develop a transportable de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. If any of these issues are problematic, the PI and research team will attempt to negotiate a fair resolution with the interested investigators and NIMHD program staff.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2019 to primary completion in Feb 2023, 38 months.

Results were first posted in Apr 2024, 1 year 1 month after primary completion.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 38 months is above that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 14, 2018
StartActual
Dec 2, 2019
Primary completionActual
Feb 27, 2023
CompletionActual
Apr 24, 2024
Results first posted
Apr 24, 2024
Last update
Oct 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03433456
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Gareth R. Dutton PhD (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Feb 14, 2018
Start date
Dec 2, 2019
Primary completion
Feb 27, 2023
Completion
Apr 24, 2024
Results posted
Apr 24, 2024
Last update
Oct 29, 2024

Study contacts

Sarah J. Salvy, PhD
principal investigator · University of Alabama at Birmingham
Gareth R. Dutton, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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